Kornimate/medical-research-clean huggingface dataset:
longitudinal assessment of health-related quality of life in men with localized prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to assess quality-of-life of men with prostate cancer. "quality-of-life" means how you feel about your life as a result of your disease and its treatment. the investigators hope that this questionnaire will help show how prostate cancer treatments affect quality-of-life. it will help doctors and future patients to make better treatment choices. some men may wish to have a more demanding treatment with a higher risk of harmful effects. others may prefer a treatment that will have the smallest effect on their quality-of-life. this questionnaire will help us measure these effects and decide which is the best treatment for a given patient.

the intent of the protocol is to assess health-related quality-of-life (hrqol) in men treated for localized prostate cancer with 1 of 6 established management alternatives: external (xrt)or interstitial radiotherapy (irt), open radical prostatectomy (rp), laparoscopic radical prostatectomy (lrp), combined radiotherapy and brachytherapy (combined rt) or watchful waiting (ww). hrqol is an important aspect of any treatment for prostate cancer due to the beliefs by many that cancer control rates are similar across common modalities and hrqol reduction from treatment is substantial (1-5). therefore, hrqol appears to occupy a central role in the decision making process related to treatment selection.

Eligibility criteria:
inclusion criteria: * diagnosis of localized, untreated prostate cancer (clinical stages t1-3, nx, m0) * ability to read the english language exclusion criteria: * other cancer diagnosis for the past three years, except for non-melanoma skin cancer * prior chemotherapy within the last three years; radiation therapy to the pelvis or prior pelvic surgery within the past three years * prior neoadjuvant therapy, such as hormones (bicalutamide use for less than or equal to 1 month would not constitute exclusion from study entry) for the cross-sectional component of the study, all patients identified to be free of disease at least ten years post -treatment will be considered eligible. patients must have no clinical evidence of local, regional or distant recurrences. patients must have the ability to read and understand english. patients who received hormonal therapy will be eligible for the cross-sectional component of the study, but the duration of the hormonal therapy must be six months or less. the investigators have identified a cohort of patients who fit these criteria from our databases.

Keywords: early stage localized
effects of obex in overweight and obese patients

Conditions: Overweight; Obesity

Summary: * obesity is an important and growing public health worldwide * obesity is highly related to the development of metabolic syndrome, diabetes, cardiovascular diseases and cancer * an extensive body of evidence from efficacy trials has shown that weight loss is achievable, however, a modest weight loss is achieved in a small proportion of patients * important adverse events have been reported with the use of antiobesity drugs. * the use of natural products with potential effects inducing weight loss is an alternative strategy for treating patients with overweight and obesity. however, efficacy and safety should be evaluated in rct. * obex combines different molecules with potential effects inducing weight loss and control on metabolic parameters such as fasting glucose, cholesterol and triglycerides. * therefore, the administration of obex in overweight and obese patients with impaired fasting glucose could be an excellent strategy to induce weight loss and ameliorate the metabolic disturbances related to obesity and overweight.


Eligibility criteria:
inclusion criteria: * overweight and obese subjects with and without ifg * ability to provide informed consent exclusion criteria: * presence of diabetes mellitus, hepatic, renal or cardiovascular disease * other diseases associated with insulin resistance (eg. acromegalia, endogenous hypercortisolism, etc) * sepsis or any other condition that could potentially interfere with treatment * history of bariatric surgery * pregnancy or lactation * concomitant disease with reduced life expectancy * severe psychiatric conditions * anyone with chronic medical conditions requiring regular intake of any prescription medications. * used drugs for weight loss (e.g., xenical \[orlistat\], meridia \[sibutramine\], acutrim \[phenylpropanolamine\], accomplia \[rimonabant\], alli \[low-dose orlistat\], or other similar over-the-counter weight loss remedies or medications) within 3 months of screening * are actively participating in, or have participated in a formal weight loss program within the last 3 months

Keywords: impaired fasting glucose prediabetes obesity overweight insulin sensitivity weight loss nutritional supplement waist body composition
point-of-care testing of respiratory pathogens at pediatric emergency room

Conditions: Respiratory Tract Infections

Summary: the main objective of the trial is to evaluate the effect of point-of-care testing of respiratory pathogens at a pediatric emergency room on the antibiotic consumption and hospital admissions in acutely ill children.

the study is a randomized controlled trial including children 0 up to 17 years of age with fever or acute respiratory infection at a pediatric emergency department in university hospital. in total 1668 subjects will be randomly allocated to undergo point-of-care multiplex respiratory pathogen testing with results ready within approximately one hour or to a control group with testing according to clinical judgement and results ready within next office day. subjects will be randomized on admission and unequal allocation ratio of 2:1 (1112 subjects to intervention and 556 subjects to control arm) will be used. data on rate of hospitalization, antibiotic prescriptions, ancillary testing and length of visit will be collected using medical record system.

Eligibility criteria:
inclusion criteria: * any respiratory symptom defined as tachypnea, shortness of breath, apnea, wheezing, cough, rhinitis, croup, sneezing, ear ache, or sore throat and/or * fever \> 38.0 c exclusion criteria: * need of resuscitation at emergency room * need of immediate transfer to pediatric intensive care unit

Keywords: anti-bacterial agents emergency room respiratory pathogen point-of-care testing patient admission pediatrics pediatric emergency medicine cost-benefit analysis antimicrobial stewardship
a phase ii multi-institutional study assessing simultaneous in-field boost helical tomotherapy for 1-3 brain metastases

Conditions: Metastasis to Brain of Primary Cancer

Summary: helical tomotherapy is a novel radiation treatment machine that combines two existing technologies: spiral radiotherapy treatments combined with simultaneous computed tomotherapy imaging of the body. this new machine can potentially allow radiation treatments to be focused more precisely, and delivered more accurately than with existing radiation machines. in this study, helical tomotherapy will be used to provide radiation treatments (whole brain radiotherapy, daily over 10 treatments) that are commonly used to treat cancer metastatic to the brain. in addition, the individual spots of cancer (metastases) in the brain will be treated to a higher dose (approximately 2 times higher) than the dose to the whole brain. the purpose of this study is to determine the effectiveness of whole brain radiation with lesion boosting with the helical tomotherapy machine.


Eligibility criteria:
inclusion criteria: * histological diagnosis of primary cancer * contrast enhanced mri demonstrating 1-3 metastases within 6 weeks of enrollment * age greater than or equal to 18 * karnofsky performance status greater than or equal to 70 * patient available for subsequent follow-up appointments and testing as well as health-related quality of life questionnaires * anticipated survival (independent of the brain metastases) greater than 3 months * patient informed consent obtained * metastatic suitable for synchronous boost * extracranial disease controlled or to be treated exclusion criteria: * underlying medical condition precluding adequate follow-up * prior cranial radiotherapy * concurrent cytotoxic chemotherapy

Keywords: 1-3 brain metastases from any primary cancer
study to assess safety and efficacy of filgotinib, lanraplenib and tirabrutinib in adults with active sjogren's syndrome

Conditions: Sjogren's Syndrome

Summary: the primary objective of this study is to assess the efficacy of filgotinib, lanraplenib, and tirabrutinib in adults with active sjogren's syndrome (sjs).


Eligibility criteria:
key inclusion criteria: * diagnosed with primary or secondary sjs according to the 2002 american european consensus group (aecg) classification * active sjs as defined by an european league against rheumatism (eular) sjogren's syndrome disease activity index (essdai) ≥ 5 * seropositivity for antibodies to sjs-associated antigens a and/or b (anti-ssa or anti-ssb) key exclusion criteria: * concurrent treatment with any biologic disease modifying antirheumatic drug (bdmard) (prior bdmard treatment allowed with appropriate washout as per study protocol) note: other protocol defined inclusion/exclusion criteria may apply.
a study of bevacizumab in combination with chemotherapy for treatment of osteosarcoma

Conditions: Osteosarcoma; Malignant Fibrous Histiocytoma (MFH) of Bone

Summary: this study adopts a novel strategy for first-line treatment of osteosarcoma by combining chemotherapy with anti-angiogenic therapy using bevacizumab (avastin®), a humanized monoclonal antibody against vascular endothelial growth factor (vegf). chemotherapy for localized disease comprises a 3-drug regimen (cisplatin, doxorubicin, and high-dose methotrexate). chemotherapy for metastatic or unresectable disease comprises a cisplatin-based regimen that includes high-dose methotrexate, doxorubicin, ifosfamide, and etoposide.

this is a comprehensive study that uses a novel agent that targets angiogenesis (bevacizumab) in combination with conventional chemotherapy for the treatment of osteosarcoma. bevacizumab, a monoclonal antibody against the vascular endothelial growth factor (vegf), has been shown to stop the growth of new blood vessels of tumors, both in the laboratory and in patients with other types of cancers. bevacizumab has improved the effect of chemotherapy in adult patients with different types of cancer by increasing tumor response and increasing the chances of survival. this study has two main goals: * to find out if bevacizumab can be combined safely with chemotherapy for osteosarcoma * to find out if adding bevacizumab to chemotherapy will be beneficial in treating osteosarcoma. the chemotherapy drugs used in this study are commonly used to treat osteosarcoma. patients with non-metastatic and resectable tumors receive bevacizumab and chemotherapy comprised of cisplatin, doxorubicin and high-dose methotrexate. patients with metastatic tumors or tumors that cannot be removed by surgery receive bevacizumab and chemotherapy comprised of cisplatin, doxorubicin and high-dose methotrexate, ifosfamide and etoposide. if the tumor can be removed by surgery, surgery will be performed after 10 weeks of chemotherapy and will be followed by additional chemotherapy. after completion of active therapy, patient's response to therapy will be followed for approximately 5 years.

Eligibility criteria:
inclusion criteria: * patient must have newly diagnosed high-grade, biopsy proven, osteosarcoma or malignant fibrous histiocytoma (mfh) of bone with no history of prior chemotherapy or radiation; * participant is able to perform tasks and daily activities as defined in the study guidelines * patient meets established guidelines for adequate function of the kidney, liver, heart and bone marrow * participants meets other requirements defined in the eligibility portion of the study exclusion criteria: * recent major surgical procedure or injury * known bleeding diathesis, platelet disorder or coagulopathy * thrombosis * cardiac disease or hypertension * significant proteinuria * central nervous system disease * gastrointestinal perforation/abdominal fistula * osteosarcoma or mfh of bone as second malignancy
"combo-key" - a home visiting and phone coaching programme to promote stroke survivors' recovery

Conditions: Stroke

Summary: building confidence and capabilities to transfer rehabilitative knowledge and skills into lifestyle-workable strategies for changing health behaviours among stroke survivors are important to optimise health outcomes and reduce risks of recurrent stroke. the aim of this project is to promote stroke survivors' health by building confidence and positive expectations of recovery outcomes, and enabling their engagement in stroke self-management behaviours.

a randomised controlled trial will be conducted to determine the effectiveness of a programme "coaching ongoing momentum building on stroke recovery journey" ("combo-key"), a home visiting and phone coaching programme, on community-dwelling stroke survivors' self-efficacy, outcome expectation, and engagement in stroke self-management behaviours. an estimated sample of 134 stroke survivors will be recruited. combo-key will be underpinned by bandura's constructs of self-efficacy and outcome expectation. it will be delivered by trained coaches. outcomes will be measured at baseline and immediately after completion of the programme. generalised estimating equations model will be used to assess the differential changes in outcome variables from pre-test to post-test between the intervention and control groups with adjustment for their baseline levels.

Eligibility criteria:
inclusion criteria: * clinically diagnosed with stroke * 18 years old or above * community dwelling * have a modified rankin scale score equal to or greater than 3 (moderate to severe disability) * have a montreal cognitive assessment score \>20 exclusion criteria: * have severe dysphasia * are diagnosed with a mental illness
oral lactobacillus rhamnosus tcell-1 and colorectal cancer

Conditions: Staged III Colorectal Cancer Receiving Adjuvant Chemotherapy

Summary: emerging evidences have shown that gut microbiota have played roles in the modulation of chemotherapy agents for cancer patients receiving chemotherapy. probiotics are gut microbiota beneficial to human body. however, little was known about the role of probiotics for cancer patients receiving chemotherapy. lactobacillus rhamnosus tcell-1 is a kind of probiotics which were isolated from the gut mucosa of healthy taiwanese. the aim of the study was to evaluate the effect of lactobacillus rhamnosus tcell-1 upon staged iii colorectal cancer patients receiving adjuvant chemotherapy.


Eligibility criteria:
inclusion criteria: 1. aged older than 20 years (inclusive) of either gender 2. expressed interest and ability to fulfill the study requirements. 3. be in general good health as determined by the first evaluation within 30 days of the first dose of lactobacillus rhamnosus tcell-1 4. able to ingest the study drug (lactobacillus rhamnosus tcell-1) dissolved in a small amount of cow's milk or soy milk orally (no feeding tube). 5. willing to prevent pregnancy - women must agree not to become pregnant or breastfeed from the time of study enrollment until at least 3 months after the last dose of study drug. if a woman is sexually active and has no history of hysterectomy or tubal ligation, she must agree to practice an acceptable method of birth control, such as hormonal or barrier birth control. a woman is eligible if she is monogamous with a vasectomized male. sexually active male volunteers without vasectomy must agree to use a barrier method of contraception for 3 months after the last dose of study drug. 6. willing to comply with protocol and report on compliance and side effects during study period. 7. informed consent obtained and signed prior to screening. exclusion criteria: 1. women who are pregnant or breast-feeding or with child-bearing potential but unable or unwilling to practice a highly effective means of contraception 2. with uncontrolled infection or serious infection within the past 4 weeks 3. patients who took antibiotics for some reasons within the past 4 weeks 4. patients who must eat probiotics product for some reasons 5. active substance abuse, including alcohol, which, in the opinion of the investigator, risks impairing the ability of the patient to comply with the protocol 6. history of allergy to any substance of investigational products 7. with known human immunodeficiency virus (hiv) infection 8. judged to be not applicable to this study by investigator such as difficulty of follow-up observation 9. with any other serious diseases/medical history considered by the investigator not in the condition to enter the trial 10. having participated other investigational study within 4 weeks of entering this study
a trial to evaluate the efficacy and safety of sibeprenlimab administered subcutaneously in participants with sjögren's

Conditions: Sjogren Disease

Summary: this is a phase 2 study to evaluate the effects of sibeprenlimab 400 mg administered subcutaneously (sc) every 4 (q4) weeks as an add-on to background treatment in participants with sjögren's disease.

this is a multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study followed by an optional open-label extension to evaluate the efficacy and safety of sibeprenlimab 400 mg administered sc q4 weeks as an add-on to background treatment in participants with sjögren's disease. the primary objective is to compare the effect of sibeprenlimab versus placebo added to background treatment on european league against rheumatism sjögren's syndrome disease activity index (essdai) scores at 28 weeks. the key secondary objective is to compare the effect of sibeprenlimab versus placebo added to background treatment on european league against rheumatism sjögren's syndrome patient-reported index (esspri) at 28 weeks. approximately 80 participants who have a diagnosis of sjögren's disease according to the 2016 american college of rheumatology (acr)/european league against rheumatism (eular) criteria will be randomized with approximately 40 participants in the sibeprenlimab group and 40 participants in the placebo group.

Eligibility criteria:
key inclusion criteria: * diagnosed with sjögren's disease. * essdai score (which measures disease activity) must be 5 or higher. * salivary flow rate must be at least 0.05 ml/min. * serum igg level must be higher than 900 mg/dl. * must be able to communicate well with the investigator and agree to follow the trial requirements. * participants can continue certain medications (hydroxychloroquine, methotrexate, leflunomide, or azathioprine) if they have been on a stable dose for at least 30 days. * corticosteroid dose must be stable and no more than 10 mg/day for at least 30 days. * test positive for anti-ro52 and/or anti-ro60 antibodies. key exclusion criteria: * another active autoimmune rheumatic disease. * prior use of b-cell depleting therapy or prohibited immunosuppressants. * significant comorbidities including uncontrolled type 2 diabetes, malignancy, and chronic and/or acute infections. * suicidal ideation or behavior based on the patient health questionnaire-9 (phq-9).

Keywords: sibeprenlimab autoimmune diseases immune system diseases dry mouth dry eyes salivary gland disorders lacrimal gland disorders immunoglobulin g envisage
australian screening mammography decision aid trial (asmdat)

Conditions: Breast Neoplasms

Summary: the purpose of the study is to develop and evaluate a decision aid to assist women aged 70 years and over to make an informed choice about whether to continue screening mammography.

the primary aims of the study are to assess the impact of the decision aid on (1) the proportion of women who make an informed choice about whether to continue screening mammography, and (2) the participation rates of screening among women aged 70 years and older. there are two secondary aims of the study. first, to measure the effect of the decision support tool on women's decisional conflict, anxiety, and knowledge about the issues involved in screening mammography. second, to compare relationships between a woman's objective and perceived risk of breast cancer with her decision to continue or stop screening mammography. screening mammography is recommended for women aged 50-69 years but there is no recommendation for women aged 70 years and older. therefore the decision to continue or stop having screening mammograms are largely dependent on the importance women place on the perceived benefits and harms of screening. the decision aid is a paper workbook and worksheet containing information on the outcomes of screening mammography for women aged 70 years and older (based on a published model- barratt et al. 2005), steps to decision making and values clarification exercise. currently it is not known if a decision aid with information about the benefits and risks of screening mammography can help women aged 70 years and older to make an informed choice. in addition to delivering benefits to individual women in assisting them to to make an informed choice the decision aid may lead to benefits for service providers such as improved efficiency and cost-effectiveness of screening women in this age group. thus the impact of a decision aid in the efficiency and cost-effectiveness of screening mammography is an important but untested hypothesis.

Eligibility criteria:
inclusion criteria: * women who are due their first screening mammogram over the age of 70, and who have previously participated in screening mammography at breastscreen nsw. exclusion criteria: * inability to complete a telephone interview in english. * personal history of breast cancer (invasive and pre-invasive).

Keywords: mammography screening breast cancer screening screening outcomes decision aid decision support tool informed choice